DATA MONITORING COMMITTEES AND PROBLEMS OF LOWER-THAN-EXPECTED ACCRUAL OR EVENT RATES

Data monitoring committees for randomized clinical trials must frequen tly decide what action, if any, is required for trials whose accrual h as been slower than expected, or whose event rates have been less than expected. We discuss in this article some of the practical issues con cerning modifying or closing such trials, including what data and anal yses could be helpful to the data monitoring committee in their delibr ations. (C) Elsevier Science Inc. 1996.